FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Pathology ×
1,109 results
241–264 of 1,109
Search insights Median review: 34d Cleared: 98% Top manufacturer: J R Scientific Lead specialty: Pathology
Cleared Nov 28, 1994
RD CULTURE CELL
K943891 · KIR
Neogenex
Pathology · 111d
Cleared Aug 26, 1994
FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE
K936271 · KIR
Diagnostic Hybrids, Inc.
Pathology · 239d
Cleared Jun 16, 1994
FRESH FROZEN CELLS
K940502 · KIR
Diagnostic Hybrids, Inc.
Pathology · 134d
Cleared Mar 31, 1994
HEP-2 CULTURE CELL
K933927 · KIR
Neogenex
Pathology · 233d
Cleared Mar 30, 1994
KAPTON PEEL POUCH
K933228 · KJA
American Fluoroseal Corp.
Pathology · 271d
Cleared Mar 29, 1994
A549 CULTURE CELL
K933923 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MCCOY CULTURE CELL
K933924 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
MRC-5 CULTURE CELL
K933925 · KIR
Neogenex
Pathology · 231d
Cleared Mar 29, 1994
LLCMK2 CULTURE CELLS
K933926 · KIR
Neogenex
Pathology · 231d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS
K936169 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY
K936171 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Feb 03, 1994
RHESUS MONKEY KIDNEY CELLS (LLC-MK2)
K936172 · KIR
Advanced Clinical Diagnostics
Pathology · 42d
Cleared Jan 28, 1994
PROFIBLOT
K933996 · KPA
Tecan U.S., Ltd.
Pathology · 164d
Cleared Jan 28, 1994
RABBIT KIDNEY CELLS - R.K.C.
K934934 · KIR
Advanced Clinical Diagnostics
Pathology · 155d
Cleared Jan 28, 1994
HELA-229/HELA CELLS
K934973 · KIR
Advanced Clinical Diagnostics
Pathology · 102d
Cleared Jan 24, 1994
PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
K935766 · KIR
Advanced Clinical Diagnostics
Pathology · 80d
Cleared Jan 03, 1994
KIDNEY AFRICAN GREEN MONKEY CELLS-CV-1
K934239 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO
K934240 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
MCCOY CULTURE CELLS-MCCOY
K934241 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.
K934242 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-2
K934243 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN LUNG DIPLOID CELLS-MRC-5
K934244 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.
K934245 · KIR
Advanced Clinical Diagnostics
Pathology · 130d
Cleared Jan 03, 1994
LUNG DIPLOID HUMAN CELLS-WI-38
K934246 · KIR
Advanced Clinical Diagnostics
Pathology · 130d